Lower risk Medical device recall · FDA · Published January 31, 2018

Cook StoneBreaker Exhaust Cap Recall: Risk of Inadequate Sterilization

Cook recalls StoneBreaker Exhaust Caps due to potential inadequate sterilization during reprocessing, affecting all units sold. Consumers should check product details and contact Cook for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1591-2018Medical device Cook ›

Lower-risk recall

The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

Take action

Contact the company

Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120

✎ GovInfoNow plain-language explainer

Cook is recalling StoneBreaker Exhaust Caps because they may not be properly sterilized when following reprocessing instructions. This could lead to infections if used in medical settings without adequate sterilization. Read more at govinfonow.com/recall/72067-cook-stonebreaker-exhaust-cap-recall-risk-of-inadequate-sterilization.

Source Summary by GovInfoNow · govinfonow.com/recall/72067-cook-stonebreaker-exhaust-cap-recall-risk-of-inadequate-sterilization · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1591-2018

Cite this page

“Cook StoneBreaker Exhaust Cap Recall: Risk of Inadequate Sterilization.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72067-cook-stonebreaker-exhaust-cap-recall-risk-of-inadequate-sterilization. Based on FDA recall #Z-1591-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1591-2018%22&limit=1).

Cook Inc. recalled StoneBreaker Exhaust Caps on Jan. 31, 2018, because the interior may not be sterilized to the appropriate Sterility Assurance Level, according to the FDA. The agency announced the Class II recall of 629 units distributed nationwide and in other countries.

How to tell if you have it

StoneBreaker Exhaust Cap
Catalog number: SBA-EC
GPN: G52599
UDI: (01)00827002525993
upc 00827002525993

The hazard

The interior of the StoneBreaker Exhaust Cap may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use, according to the FDA.

Context

GovInfoNow's records show Cook Inc. has issued 38 other recalls since July 31, 2017. Recent Cook recalls include a Nov. 12, 2021, recall of Flexor Check-Flo Introducers for mislabeling risk and an Oct. 13, 2021, recall of Skinny Needles with Chiba Tips due to black debris risks. Other recent recalls of similar products include a Nov. 26, 2025, Cook Ring Transjugular Intrahepatic Access Sets recall for manufacturing defect risk and an Oct. 8, 2021, Cook Transseptal Needle recall for rust risks.

How to tell if you have this one

Check for the catalog number SBA-EC, GPN G52599, or UDI (01)00827002525993 on the product. All lots of this exhaust cap are affected.

Brand
Cook
Product
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
Category
Medical device

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TT, TW, UA, UY, XK, ZA

Recall number	Product, codes & lots	Quantity
Z-1590-2018	StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044; All Lots	751
Z-1591-2018	StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993; All Lots	629
Z-1592-2018	StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006; All Lots	760
Z-1593-2018	StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013; All Lots	370
Z-1594-2018	StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020; All Lots	470
Z-1595-2018	StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034; All Lots	38,542
Z-1596-2018	StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608; All Lots	12,556

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the catalog number SBA-EC, GPN G52599, or UDI (01)00827002525993 on the exhaust cap.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Jan 31, 2018Firm started the recall
May 2, 2018FDA classified it Class II
May 9, 2018Published in FDA’s Enforcement Report
Apr 17, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72067-cook-stonebreaker-exhaust-cap-recall-risk-of-inadequate-sterilization">Cook StoneBreaker Exhaust Cap Recall: Risk of Inadequate Sterilization (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1591-2018 (January 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1591-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.